Trial Examines Short-term Effects of Hippotherapy on Fascia Properties and Quality of Life in Children With CP.

NCT ID: NCT07134582

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-01-31

Brief Summary

The effects of hippotherapy on gross motor function, balance, and spasticity in children with cerebral palsy (CP) are well-documented, but its impact on the thoracolumbar fascia (TLF) remains unexplored area to date. This research protocol aims to investigate the short-term effects of hippotherapy on the viscoelastic and biomechanical properties of the TLF and quality of life (QoL) in children with spastic CP and their parents/caregivers. A 4-week randomized control trial will compare the effects of once-weekly and twice-weekly hippotherapy sessions to a control group without intervention. The study will assess the viscoelastic and biomechanical properties of the TLF using the MyotonPRO device in children with spastic CP aged 4-12 years. Myotonometer parameters, including oscillation frequency, stiffness, logarithmic decrement, stress relaxation, and creep, will be analyzed before, during, and after the intervention. Functional tests, such as the 10-meter walk test (comfortable and fast walking), cadence, one-leg stance test (eyes open and closed), and functional reach test (forward and lateral), will also be monitored. QoL will be assessed using the CP QOL-Child questionnaire. The primary outcomes will include changes in myotonometer parameters, their correlation with functional tests, and differences between intervention groups. Secondary outcomes will explore whether hippotherapy impacts QoL and the relationship between QoL domains and TLF properties. Results will evaluate whether twice-weekly therapy yields statistically significant differences in the specified parameters compared once-weekly sessions and contribute to understanding hippotherapy's mechanisms, supporting more individualized therapies to improve QoL for children with CP and their families.

Conditions

Cerebral Palsy (CP); Rehabilitation; Motor Coordination or Function; Hippotherapy; Fascia; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hippotherapy 1x/week

Group Type: EXPERIMENTAL

Hippotherapy 1x/week

Intervention Type: OTHER

This group will perform hippotherapy once per week for 12 weeks

Hippotherapy 2x/week

Group Type: EXPERIMENTAL

Hippotherapy 2x/week

Intervention Type: OTHER

This group will perform hippotherapy twice per week for 12 weeks

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hippotherapy 1x/week

This group will perform hippotherapy once per week for 12 weeks

Intervention Type: OTHER

Hippotherapy 2x/week

This group will perform hippotherapy twice per week for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• classified as level II or III according to the GMFCS, and who, according to the assessment of a specialist physician, are indicated for hippotherapy aged between 4 and 12 years
• who are undergoing neurophysiotherapeutic treatment
• who have not undergone orthopedic surgery in the last six months and do not have uncontrolled epilepsy
• are willing to be randomly assigned to any group (or whose parents/caregiver's consent)
• understand instructions in Slovene and are willing to participate in the study for four weeks (or whose parents/ caregiver's consent)
• without skin diseases, scars, or wounds on the examined part of the back

Exclusion Criteria

• who have previously participated in a hippotherapy program
• with a known and diagnosed psychiatric disorder for which hippotherapy is contraindicated
• with limitations due to hearing or visual impairment
• with painful adductor contractures, painful subluxation, or hip dislocation are not willing to be randomly assigned to any group (or whose parents/caregiver's consent)
• who are afraid of horses or have an allergy to horsehair
• with skin diseases, scars, or wounds on the examined part of the back

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Konjeniški zavod Epona

Novo Mesto, Dolenjska, Slovenia

Countries

Slovenia

Central Contacts

Sabina Devjak Novak, PhD

Role: CONTACT

sabina.d.novak@gmail.com

+38640294213

Facility Contacts

Sabina Devjak Novak, Phd

Role: primary

sabina.d.novak@gmail.com

+38640294213

Other Identifiers

HYPPOTER25

Identifier Type: -

Identifier Source: org_study_id